Wang 2009a.
Methods | Study design: randomised controlled trial. Method of randomisation: no description. Concealment of allocation: no description. Exclusions post randomisation: none. Losses to follow‐up: none. Intention‐to‐treat analysis: not mentioned. | |
Participants | Participants were those who underwent PCI successfully (residual stenosis < 20%), aging from 35 to 74. Tong‐xin‐luo group: 40 participants (male/female: 28/12; age: 54.2 ± 10.2 years). Control group: 40 participants (male/female: 26/14; age: 52.5 ± 11 years). |
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Interventions | Control group: Conventional treatment (low molecular weight heparin 6000 IU subcutaneous injection bid for 5 days; aspirin 100 mg qd, clopidogrel 75 mg qd). Tong‐xin‐luo group: conventional treatment plus Tong‐xin‐luo capsules (3 capsules, tid; 0.38 g/capsule). Duration of intervention: 6 months. Co‐intervention: none. |
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Outcomes | Occurrence of myocardial infarction and angina. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, but detailed information on the randomisation method was not provided. |
Allocation concealment (selection bias) | Unclear risk | No description about the allocation procedure. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No description about blinding. No placebo. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No description about blinding. No placebo. |
Incomplete outcome data (attrition bias) Angiographic restenosis | Unclear risk | The outcome was not reported. |
Incomplete outcome data (attrition bias) Outcomes other than angiographic restenosis | Low risk | There was no loss to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | The study protocol is not available. |
Other bias | Low risk | Baseline information showed no statistical differences in sex, age, smoking, comorbidities, length of lesion and distributions of coronary pathological changes between the two groups (P > 0.05). The study appeared to be free of other sources of bias. |